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Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515487-31-00
Acronym
103900
Enrollment
163
Registered
2024-10-16
Start date
Unknown
Completion date
2025-12-12
Last updated
2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-infected

Brief summary

AUC0-tau; Cmax; Ctrough, tmax, thalf for pregnant women. Comparison between these parameters during pregnancy and the parameters after pregnancy using mixed model analysis ., Ctrough in pregnancy should be above the minimal effective plasma concentration., Cord blood/maternal blood concentration ratio at delivery., Determination of half life in infants after in utero exposure if applicable (washout half life)., Breastmilk/maternal plasma ratio in case of breastfeeding and exposure in child if breastfeeding.

Detailed description

Description of maternal viral suppression during pregnancy and postpartum., Description of infection status of infants at birth., Description of SAEs and AEs reported during pregnancy and postpartum.

Interventions

DRUGZiagen 300 mg film-coated tablets
DRUGINTELENCE 200 mg tablets
DRUGEviplera 200 mg/25 mg/245 mg film-coated tablets
DRUGEDURANT 25 mg film-coated tablets
DRUGTelzir 700 mg film-coated tablets
DRUGTRIZIVIR 300 mg/150 mg/300 mg film-coated tablets
DRUGDelstrigo 100 mg/300 mg/245 mg film-coated tablets
DRUGNorvir 100 mg film-coated tablets
DRUGRitonavir Accord 100 mg filmomhulde tabletten
DRUGDescovy 200 mg/10 mg film-coated tablets
DRUGREYATAZ 300 mg hard capsules
DRUGREKAMBYS 600 mg prolonged-release suspension for injection
DRUGTivicay 50 mg film-coated tablets
DRUGREKAMBYS 900 mg prolonged-release suspension for injection
DRUGViread 245 mg film-coated tablets
DRUGEmtriva 200 mg hard capsules
DRUGDescovy 200 mg/25 mg film-coated tablets
DRUGCELSENTRI 300 mg film-coated tablets
DRUGTruvada 200 mg/245 mg film-coated tablets
DRUGBiktarvy 50 mg/200 mg/25 mg film-coated tablets
DRUGOdefsey 200 mg/25 mg/25 mg film-coated tablets
DRUGSTOCRIN 600 mg film-coated tablets
DRUGVocabria 400 mg prolonged-release suspension for injection
DRUGINTELENCE 100 mg tablets
DRUGAptivus 250 mg soft capsules
DRUGPifeltro 100 mg film-coated tablets
DRUGCELSENTRI 150 mg film-coated tablets
DRUGKivexa 600 mg/300 mg film-coated tablets
DRUGISENTRESS 400 mg film-coated tablets
DRUGFuzeon 90 mg/ml powder and solvent for solution for injection
DRUGVocabria 600 mg prolonged-release suspension for injection
DRUGISENTRESS 600 mg film-coated tablets

Sponsors

Stichting Radboud universitair medisch centrum
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
AUC0-tau; Cmax; Ctrough, tmax, thalf for pregnant women. Comparison between these parameters during pregnancy and the parameters after pregnancy using mixed model analysis ., Ctrough in pregnancy should be above the minimal effective plasma concentration., Cord blood/maternal blood concentration ratio at delivery., Determination of half life in infants after in utero exposure if applicable (washout half life)., Breastmilk/maternal plasma ratio in case of breastfeeding and exposure in child if breastfeeding.—

Secondary

MeasureTime frame
Description of maternal viral suppression during pregnancy and postpartum., Description of infection status of infants at birth., Description of SAEs and AEs reported during pregnancy and postpartum.—

Countries

Belgium, Germany, Ireland, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026